Twelve-month Results of the EverFlex Stent in the Superficial Femoral Artery

doi:10.1016/j.jvir.2012.05.045

Journal of Vascular and Interventional Radiology

Volume 23, Issue 10, October 2012, Pages 1317-1322

https://doi.org/10.1016/j.jvir.2012.05.045 Get rights and content

Abstract

Purpose

To evaluate the clinical efficacy of EverFlex stents (length, 6–20 cm) for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA).

Material and Methods

Over a period of 18 months, 56 SFA lesions in 53 patients were treated with an EverFlex stent. The following parameters were documented before the intervention, immediately afterward, and 12 months later: clinical stage, ankle-brachial index, and peak systolic velocity ratio (PSVR). The primary study endpoint was the primary patency rate after 12 months (defined as a PSVR < 2.5).

Results

In 18% of the 56 lesions, complete occlusions were present. Mean lesion length was 9.4 cm ± 5.3, and mean stent length was 12.6 cm ± 5.6. Of the 53 patients enrolled in the study, a 12-month follow-up was performed in 46. The primary patency rate after 12 months was 71.7%. In-stent restenosis or occlusion occurred in 13 patients. Compared with the total study group, the mean stent length in these 13 patients was greater (14.0 cm ± 7.3) and the incidence of de novo lesions was lower. In the patient group with stents less than 10 cm in length (n = 24), six patients (25%) required a repeat intervention, compared with seven patients (32%) in the group with stents longer than 12 cm.

Conclusions

Although the primary patency rate associated with the EverFlex stent is comparable to those in published data, the present results demonstrate a higher percentage of in-stent stenoses in patients in whom longer SFA stents were implanted.

Section snippets

Materials and Methods

From June 2008 to January 2010, 53 patients with de novo, restenotic, or reoccluded SFA lesions were treated with the Protégé EverFlex stent (ev3) at our interventional unit. This dedicated, self-expanding stent is premounted on a 6-F, 0.035-inch, over-the-wire delivery system. For clinical use, the stent is available in various lengths, starting from 60 to 200 mm, and in two diameters of 6 and 7 mm. In all patients with PAD who were recruited for therapeutic angiography, the clinical symptoms

Results

Of the 53 patients included in this retrospective study, a follow-up examination was performed in 46. Among the remaining seven patients, five had died and two had moved to another location. One target lesion was treated in each of 50 patients, and three patients underwent treatment of two contiguous target lesions in the same SFA. Table 1 shows the demographic data and the risk factors of the treated patients.

The mean lesion length was 9.4 cm ± 5.3 (Fig 1). Of 56 lesions, 26 (46%) involved

Discussion

For the treatment of complex SFA lesions associated with extensive occlusive disease, the indications for endovascular interventional procedures are growing and the results are promising. Considering the fact that current stent designs are constantly being optimized and that the technical developments of the devices and procedures are immense, some authors support present interventional procedures and strongly recommend extending the spectrum of therapeutic interventional techniques (8, 9, 10,

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Cited by (11)

IN.PACT™ Admiral™ drug-coated balloon: Durable, consistent and safe treatment for femoropopliteal peripheral artery disease
2017, Advanced Drug Delivery Reviews
Endovascular management of peripheral artery disease was until recently limited to percutaneous balloon angioplasty, atherectomy, stent grafts, and bare-metal stents. These therapies have been valuable, but plagued by high restenosis and revascularization rates. Important progress has been made with the introduction of combination devices, including drug-eluting stents and drug-coated balloons (DCB), designed to combat restenosis by locally delivering anti-proliferative drugs. In particular, promising clinical performance has been seen with the Medtronic IN.PACT™ Admiral™ DCB, with durable, consistent and safe results. Rigorous, randomized controlled trials have directly compared this and other drug-delivering devices to their non-drug-coated counterparts with data available through two years. Additionally, trials are ongoing to assess use of drug-coated technologies in combination with traditional therapies in hope of synergistic effects. This review gathers data from currently published clinical trials with the IN.PACT Admiral DCB for the treatment of femoropopliteal peripheral artery disease and explores the possible impact on continuing clinical practice.
Results of primary stent therapy for femoropopliteal peripheral arterial disease at 7 years
2016, Journal of Vascular Surgery
Citation Excerpt :
Similarly, miscellaneous studies revealed satisfying midterm and long-term outcomes of nitinol stent implantation, whereas the reported PPR at 5 years varies between 41% and 79.5%.4,9,10 In contrast to the findings of Diehl et al,11 the lesion length did not affect stent performance. Notably, the decline of PPR was not continuous, and a significant loss of patency was observed during the first 12 months and between 36 and 48 months after the procedure.
Primary stenting is a well-established treatment option for femoropopliteal arterial disease. However, there is a paucity of data concerning the performance of this modality at ≥5 years. This study evaluated the long-term clinical and radiologic outcomes of primary stent therapy in patients with femoropopliteal arterial disease.
A prospective data collection and analysis was conducted in patients undergoing primary stent placement in femoropopliteal lesions between September 2006 and September 2007. The EverFlex (Medtronic/Covidien, Plymouth, Minn) bare-metal stent was used. The primary outcome of this study was the primary patency rate. Secondary outcomes were secondary patency rate, amputation-free-survival (AFS), and freedom from target lesion revascularization (TLR). A Cox regression analysis identified risk factors for the primary and the secondary measure outcomes.
Included were 89 patients (102 stents). The prevalence of critical limb ischemia was 34% (n = 30). The initial angiography revealed a TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease C/D lesion in 31 patients (35%). Occlusions were present in 49 patients (55%), and the mean lesion length was 116 ± 33 mm. Popliteal artery disease was present in 39 treated limbs (35%). The primary patency rate at 1, 3, 5, and 7 years was 73%, 64%, 47%, and 33% respectively. At 7 years, secondary patency rate was 67%, freedom from TLR was 47%, and the AFS was 73%. Cox regression analysis revealed a decreased AFS among diabetic patients (hazard ratio [HR], 2.6; 95% confidence interval [CI], 1.08-6.28; P = .03), whereas secondary endovascular interventions showed a protective effect for AFS (HR, 0.14; 95% CI, 0.03-0.65; P = .01). Popliteal artery disease was identified as independent risk factor for secondary interventions (HR, 2.07; 95% CI, 1.05-4.06; P = .04) and TLR (HR, 1.99; 95% CI, 1.03-3.83; P = .04). Critical limb ischemia was associated with an increased incidence of surgical conversion owing to endovascular treatment failure (HR, 5.46; 95% CI, 2.44-12.17; P < .001).
This study found primary stenting was associated with acceptable clinical and radiologic long-term outcomes. Diabetes was associated with poor AFS, and popliteal artery involvement correlated with an increased need for reinterventions. AFS was better among patients undergoing secondary procedures.
SUPERA interwoven nitinol stent outcomes in above-knee intErventions (SAKE) study
2014, Journal of Vascular and Interventional Radiology
To report experience with the novel interwoven-wire self-expanding nitinol SUPERA stent (IDEV Technologies, Inc/Abbott Laboratories, Inc, Webster, Texas) for the treatment of severely diseased superficial femoral and popliteal arteries.
Consecutive patients with severely diseased superficial femoral and popliteal arteries who received SUPERA stents (n = 80 patients [98 limbs]; mean age, 70.8 y; 80% male) were retrospectively identified. Patients were followed for an average of 14.3 months after intervention.
Total occlusions were present in 39% of the lesions, 21% had tissue loss, and 61% demonstrated calcification on fluoroscopy. Patients were prescribed dual antiplatelet therapy (aspirin and clopidogrel) for at least 30 days unless contraindicated, followed by aspirin alone indefinitely. The mean (± SD) lesion length was 143 mm (± 98). Based on need for clinical intervention, primary patency was 96.9% at 6 months and 85.8% at 12 months (Kaplan-Meier estimates). Assisted primary patency and secondary patency rates at 12 months were 96.8% and 100%, respectively. Ankle-brachial index increased from 0.60 at baseline to 0.83 at last follow-up (P < .001). No stent fractures were found by fluoroscopy inspection in 19 limbs (16 patients) that required reintervention.
Based on experience with multiple operators at a single clinical center, the interwoven nitinol stent design provides a viable option for high-grade obstructive disease in the femoropopliteal artery.
Direct stent puncture technique for intraluminal stent recanalization in the superficial femoral and popliteal arteries in-stent occlusion: Outcomes from a prospective clinical analysis of diabetics with critical limb ischemia
2013, Cardiovascular Revascularization Medicine
Citation Excerpt :
Important advances in technology have led to the development of self-expanding nitinol stents, which have significantly improved intermediate outcomes of superficial femoral artery (SFA) stenting in several prospective clinical trials [5–10]. However, in a long-term follow up [11,12] the most important complication of endovascular stenting is the in-stent occlusion [13–18]. The options to treat in-stent occlusion are endovascular or open surgery intervention.
To evaluate the efficacy and safety of “Direct Stent Puncture” technique for intraluminal stent recanalization in the femoro-popliteal segments.
A cohort of diabetics who had symptomatic in-stent occlusion of the superficial femoral or popliteal arteries underwent endovascular recanalization. After antegrade failure, direct stent puncture technique was performed.
The primary end-point was to efficacy assessment, intended as technical success and clinical improvement. The secondary end-point was safety assessment, intended as free of complication rate.
Fifty-four patients (37 men; 73.6 ± 8.5 years) underwent direct stent puncture technique, after several unsuccessful antegrade attempts to cross the occluded stent. Technical success for intraluminal stent recanalization was achieved in 53/54 (98.2%) of cases and failed in 1/54 (1.8%).
Clinical improvement was obtained in 51/54 (94.4%) of cases, with regression of the clinical symptoms and improvement of the TcPO₂, from 3 ± 18 mmHg to 43 ± 11 mmHg after 15 days (p < 0.001).
Free of complications rate was 92.5%. In 2/54 (3.7%) of cases distal embolization occurred, in 1/54 (1.9%) case a sudden vessel thrombosis was diagnosed after 12 hours and in 1/54 (1.9%) case hematoma at the stent puncture site was observed.
Direct Stent Puncture technique is an efficacy and safety option for intraluminal stent recanalization in the femoro-popliteal segment in-stent occlusion.
Ever done or moving on?
2012, Journal of Vascular and Interventional Radiology
A review on femoropopliteal arterial deformation during daily lives and nickel-titanium stent properties
2022, Journal of Medical Engineering and Technology

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: None of the authors have identified a conflict of interest.

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Clinical studyTwelve-month Results of the EverFlex Stent in the Superficial Femoral Artery

Abstract

Purpose

Material and Methods

Results

Conclusions

Section snippets

Materials and Methods

Results

Discussion

J Am Coll Cardiol

J Vasc Surg

J Vasc Surg

J Vasc Surg

Efficacious use of nitinol stents in the femoral and popliteal arteries

J Vasc Surg

Endovascular interventions in iliac and infrainguinal occlusive artery disease

J Intervent Cardiol

Clinical study
Twelve-month Results of the EverFlex Stent in the Superficial Femoral Artery